Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047366
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-09-14
Brief Title:
Combination of Buffered Anesthetic to Treat Mandibular Molars
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Buffered vs Unbuffered Local Anesthesia Using Lidocaine Carbocaine and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether a combination of anesthetics numbing medicine will adequately anesthetize teeth over a different combination A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics
Detailed Description:
60 human subjects with Symptomatic Irreversible Pulpitis SIP in mandibular molars will be randomly allocated into 2 groups One group will receive a combination of 1 cartridge of buffered 2 lidocaine w 1100k epi via inferior alveolar nerve block IANB followed by 1 cartridge of 3 mepivacaine via IANB This will be followed by 05 cartridges 09mL of buffered 4 articaine with 1100k epi via buccal infiltration and 05 cartridges of buffered 4 articaine with 1100k epi via lingual infiltration All IANB injections will include a lingual block The second group will be provided an unbuffered version of the same combination An electronic pulp tester EPT will be used to determine the vitality of the treated tooth Endodontic treatment will be initiated after two consecutive EPT readings of 80 displaying pulpal anesthesia Profound pulpal anesthesia is described by the patients report on the visual analog scale after the pulpotomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None